# K024200: Innova 2000 and Innova 2000S (Mobile Version)

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, Inc.
- Decided: Jan 16, 2003 after 27 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890348 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022322: Innova and Innova 2000 S, Ge Medical Systems, Inc. (2002) Summary page 1.

## Recalls of this device
- Jun 10, 2010 · Not classified · Z-2238-2010: A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance (SID) failure, which will cause the imager to fail to 
- Dec 22, 2009 · Not classified · Z-0620-2010: Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potentia
- Aug 6, 2009 · Not classified · Z-0393-2011: GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE eq
- Jul 31, 2009 · Not classified · Z-2240-2009: GE Healthcare has recently became aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE e
- Jul 25, 2008 · Not classified · Z-2435-2008: The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.
- Jan 14, 2008 · Not classified · Z-2042-2008: Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system
- Mar 6, 2006 · Not classified · Z-0896-06: Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.

## Indications for use
The Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional cardiac angiography and optionally, rotational cardiac angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional cardiac angiography procedures. They can be operated in a mobile as well as a fixed site environment.

Source page: https://510kreport.com/device/K024200
Methodology: https://510kreport.com/methodology